Major Depressive DisorderPhase 1NCT04623814
the Safety, Tolerability, and Pharmacokinetics Study of HEC113995
A Phase 1 study testing Food and HEC113995 in people with Major Depressive Disorder, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Food and HEC113995
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2020to 12 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
- 2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- 3. Subjects aged between 18 and 45 (both inclusive) years old.
- 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
- 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Who cannot join
- 1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- 2. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
- 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
- 4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- 6. Positive results from urine drug screen test.
Show all 13Show fewer
- 7. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- 8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
- 9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
- 10. Subjects who plan to receive or have had organ transplants.
- 11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- 12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- 13. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects
Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects
- Conditions
- Major Depressive Disorder
- Being tested
- Food, HEC113995, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
HEC113995 20mg will be taken orally fasted or with food
HEC113995Drug
HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
placeboDrug
The placebo will be administered fasted or with food for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Food effect | Experimental | HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once. Receives: Other: Food |
| Multiple Ascending Doses-HEC113995 10mg | Experimental | HEC113995 10mg will be administered fasted for 10 days Receives: Drug: HEC113995 |
| Multiple Ascending Doses-HEC113995 20mg | Experimental | HEC113995 20mg will be administered with food for 10 days Receives: Drug: HEC113995 |
| Multiple Ascending Doses-HEC113995 40mg | Experimental | HEC113995 40mg will be administered with food for 10 days Receives: Drug: HEC113995 |
| Multiple Ascending Doses-placebo | Placebo comparator | Placebo arms will be administered fasted or with food for 10 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
To assess the safety and tolerability of therapy
Measured: up to 34 days
Secondary outcomes (10)
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
Measured: up to 120 hours
Maximum Plasma Concentration （ Cmax）
Measured: up to 120 hours
Time to peak（tmax）
Measured: up to 120 hours
Apparent terminal elimination half-life（t½）
Measured: up to 120 hours
Apparent volume of distribution（Vz/F）
Measured: up to 120 hours
The Mean Residence Time（ MRT）
Measured: up to 120 hours
The Apparent Clearance （CL/F）
Measured: up to 120 hours
The Accumulation Ratio（R）
Measured: up to 120 hours
Food Effect on the Cmax
Measured: up to 120 hours
Food Effect on the AUC
Measured: up to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Mar 2020
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623814
- Sponsor's protocol ID
- HEC113995-P-04/CRC-C2006
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04623814
- Acronym / sponsor ID
- HEC113995-P-04/CRC-C2006
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Food effect | Experimental | Other: FoodHEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once. |
| Multiple Ascending Doses-HEC113995 10mg | Experimental | Drug: HEC113995HEC113995 10mg will be administered fasted for 10 days |
| Multiple Ascending Doses-HEC113995 20mg | Experimental | Drug: HEC113995HEC113995 20mg will be administered with food for 10 days |
| Multiple Ascending Doses-HEC113995 40mg | Experimental | Drug: HEC113995HEC113995 40mg will be administered with food for 10 days |
| Multiple Ascending Doses-placebo | Placebo comparator | Drug: placeboPlacebo arms will be administered fasted or with food for 10 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
- 2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- 3. Subjects aged between 18 and 45 (both inclusive) years old.
- 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
- 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Key exclusion criteria (13 listed)
- 1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- 2. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
- 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
- 4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodHEC113995 20mg will be taken orally fasted or with food | Other | Food effect |
| HEC113995HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days | Drug | Multiple Ascending Doses-HEC113995 10mg, Multiple Ascending Doses-HEC113995 20mg, Multiple Ascending Doses-HEC113995 40mg |
| placeboThe placebo will be administered fasted or with food for 10 days. | Drug | Multiple Ascending Doses-placebo |
Primary outcome
Adverse event
Time frame: up to 34 days
To assess the safety and tolerability of therapy
10 secondary outcomes
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
Time frame: up to 120 hours
Maximum Plasma Concentration （ Cmax）
Time frame: up to 120 hours
Time to peak（tmax）
Time frame: up to 120 hours
Apparent terminal elimination half-life（t½）
Time frame: up to 120 hours
Apparent volume of distribution（Vz/F）
Time frame: up to 120 hours
The Mean Residence Time（ MRT）
Time frame: up to 120 hours
The Apparent Clearance （CL/F）
Time frame: up to 120 hours
The Accumulation Ratio（R）
Time frame: up to 120 hours
Food Effect on the Cmax
Time frame: up to 120 hours
Food Effect on the AUC
Time frame: up to 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Food and HEC113995 in people with Major Depressive Disorder, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: up to 34 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.